The Basics
What is Ustekinumab?
Used to treat moderate to severe plaque psoriasis.
Brand names for Ustekinumab
Stelara
How Ustekinumab is classified
Antibodies – Monoclonal, Dermatologic Agents
Ustekinumab During Pregnancy
Ustekinumab pregnancy category
Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Ustekinumab while pregnant
There is a pregnancy registry that monitors pregnancy outcomes in women exposed to STELARA® during pregnancy. Patients should be encouraged to enroll by calling 1-877-311-8972. Risk Summary Limited data on the use of STELARA® in pregnant women are insufficient to inform a drug associated risk . In animal reproductive and developmental toxicity studies, no adverse developmental effects were observed after administration of ustekinumab to pregnant monkeys at exposures greater than 100 times the human exposure at the maximum recommended human subcutaneous dose (MRHD). All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage of clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Taking Ustekinumab While Breastfeeding
What are recommendations for lactation if you're taking Ustekinumab?
Limited published information is available on the clinical use of ustekinumab during breastfeeding. It is usually either not detectable in breastmilk or detectable at very low levels. Absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. If ustekinumab is required by the mother, it is not a reason to discontinue breastfeeding and some experts consider it a good choice in nursing women with psoriasis.[1][2][3] Until more data become available, ustekinumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Ustekinumab is a human immunoglobulin G1 (IgG1) kappa antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G by up to 79%.[4][5] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with IgG1 activity decreasing by about 37%.[6] None of the studies measured IgG activity. Ustekinumab is unstable in breastmilk, with up to a 26% decrease in drug concentration when stored for 24 hours at room temperature.[7]
Maternal / infant drug levels
Limited published information is available on the clinical use of ustekinumab during breastfeeding. It is usually either not detectable in breastmilk or detectable at very low levels. Absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. If ustekinumab is required by the mother, it is not a reason to discontinue breastfeeding and some experts consider it a good choice in nursing women with psoriasis.[1][2][3] Until more data become available, ustekinumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Ustekinumab is a human immunoglobulin G1 (IgG1) kappa antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G by up to 79%.[4][5] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with IgG1 activity decreasing by about 37%.[6] None of the studies measured IgG activity. Ustekinumab is unstable in breastmilk, with up to a 26% decrease in drug concentration when stored for 24 hours at room temperature.[7]
Possible effects of Ustekinumab on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Ustekinumab
(Psoriasis) Adalimumab, Etanercept, Infliximab, Phototherapy, Tretinoin.
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Gotestam Skorpen C, Hoeltzenbein M, Tincani A et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016;75:795-810. PMID: 26888948
2. Amin M, No DJ, Egeberg A et al. Choosing first-line biologic treatment for moderate-to-severe psoriasis: What does the evidence say? Am J Clin Dermatol. 2018;19:1-13. PMID: 29080066
3. Mahadevan U , Robinson C, Bernasko N et al. Inflammatory bowel disease in pregnancy clinical care pathway: A report from the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology. 2019;156:1508-24. PMID: 30658060
4. Koenig A, de Albuquerque Diniz EM, Barbosa SF et al. Immunologic factors in human milk: The effects of gestational age and pasteurization. J Hum Lact. 2005;21:439-43. PMID: 16280560
5. Adhisivam B, Vishnu Bhat B, Rao K et al. Effect of Holder pasteurization on macronutrients and immunoglobulin profile of pooled donor human milk. J Matern Fetal Neonatal Med. 2018;1-4. PMID: 29587541
6. Rodriguez-Camejo C, Puyol A, Fazio L et al. Antibody profile of colostrum and the effect of processing in human milk banks: Implications in immunoregulatory properties. J Hum Lact. 2018;34:137-47. PMID: 28586632
7. Klenske E, Osaba L, Nagore D et al. Drug levels in the maternal serum, cord blood and breast milk of a ustekinumab-treated patient with Crohn’s disease. J Crohns Colitis. 2019;13:267-9. PMID: 30388211
8. Matro R, Martin CF, Wolf D et al. Exposure concentrations of infants breastfed by women receiving biologic therapies for inflammatory bowel diseases and effects of breastfeeding on infections and development. Gastroenterology. 2018;155:696-704. PMID: 29857090
9. Lund T, Thomsen SF. Use of TNF-inhibitors and ustekinumab for psoriasis during pregnancy: A patient series. Dermatol Ther. 2017;30:e12454. PMID: 28071837
10. Mugheddu C, Atzori L, Lappi A et al. Biologics exposure during pregnancy and breastfeeding in a psoriasis patient. Dermatol Ther. 2019;32:e12895 PMID: 30958637
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
